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Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)

2 januari 2014 bijgewerkt door: HealthCore-NERI

Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study

This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with prednisone.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

ITP is a common disorder associated with significant morbidity. For more than 40 years it has been recognized that this disorder was responsive to corticosteroid therapy. As corticosteroids are easily obtainable and inexpensive, they have become the standard first-line therapy for adult patients with newly-diagnosed ITP. Generally, patients are treated with prednisone at a dose of approximately 1 mg/kg, or 60 mg/day, and once a response is obtained the daily dosage is gradually tapered. While approximately 70% of patients treated in this manner respond initially, most will relapse as the corticosteroid dose is lowered; ultimately only 15-20% of patients achieve a complete or partial remission of their ITP at an "acceptable" dose of prednisone. Recently, several studies have suggested that the use of high dose corticosteroids, specifically pulse dexamethasone, may be a more efficacious initial therapy for ITP, capable of causing a higher initial response rate and a significantly longer duration of remission despite a shorter course of initial therapy.

This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with standard oral corticosteroids. This may reflect the ability of high dose corticosteroids to eradicate a sensitive pathogenic lymphoid clone that may be transiently susceptible to aggressive immunosuppressive therapy early in the course of disease.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

8

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70112
        • Tulane University
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • University of Maryland
      • Baltimore, Maryland, Verenigde Staten, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Children's Hospital Boston
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Brigham & Women's Hospital
    • New York
      • New York, New York, Verenigde Staten, 10021
        • Weill Medical College, Cornell University
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • University of North Carolina Hospitals
      • Durham, North Carolina, Verenigde Staten, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • The University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • University of Pittsburgh Presbyterian and Shadyside Hospital
    • Washington
      • Seattle, Washington, Verenigde Staten, 98195
        • University of Washington Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, Verenigde Staten, 54601
        • Gundersen Clinic
      • Madison, Wisconsin, Verenigde Staten, 53792
        • University of Wisconsin

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Must meet criteria for a diagnosis of ITP as specified by ASH guidelines
  • Must be within 30 days after diagnosis of ITP at the time of randomization (diagnosis of ITP starts with first platelet count ≤ 100,000/μl)
  • Platelet count ≤ 30,000/μl at the time ITP is diagnosed, and/or at some time between the diagnosis of ITP and study entry
  • Platelet count ≤ 150,000/μl at the time of randomization
  • Age ≥ 15 years
  • If bone marrow examination is available, it must be compatible with ITP
  • Subjects, or their legal guardians, must have the ability to provide informed consent

Exclusion Criteria:

  • Rituximab therapy or splenectomy for ITP or for any other cause within the previous 8 weeks.
  • Known HIV infection
  • Known HCV infection
  • Known systemic lupus erythematosus
  • Pregnancy or breastfeeding
  • Insulin-requiring diabetes mellitus
  • Previous exposure to prednisone for ITP at a dose ≥ 1.5 mg/kg prednisone/day for ≥ 1 week prior to study entry
  • Ongoing use of treatments that are known to inhibit platelet function, e.g. aspirin
  • Anything that in the opinion of the investigator is likely to interfere with participation in the study
  • Persons previously randomized in the ITP^2 study
  • Persons currently enrolled in other interventional clinical trials
  • Exposure to thrombopoietic agent prior to study entry
  • Previous exposure to dexamethasone for the treatment of ITP at a dose of 30 mg/day or greater for subjects < 60 kg or 40 mg/day or greater for subjects >= 60 kg for at least four days

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: High dose pulse dexamethasone
Geneesmiddel: Dexamethasone USP Micronized
The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Actieve vergelijker: Standard prednisone therapy
Geneesmiddel: Prednisone
Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.
Tijdsspanne: From 60 days through 365 days after study entry.
From 60 days through 365 days after study entry.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry
Tijdsspanne: From 60 days through 365 days after study entry
From 60 days through 365 days after study entry
The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365
Tijdsspanne: 365 days after study entry
365 days after study entry
The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry
Tijdsspanne: From 180 days through 365 days after study entry
From 180 days through 365 days after study entry
The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry
Tijdsspanne: From 180 days through 365 days after study entry
From 180 days through 365 days after study entry
The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry
Tijdsspanne: Through 60 days after study entry
Through 60 days after study entry
The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry
Tijdsspanne: From 60 days through 365 days after study entry
From 60 days through 365 days after study entry
The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)
Tijdsspanne: From 60 days through 365 days after study entry
From 60 days through 365 days after study entry
The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)
Tijdsspanne: From 60 days through 365 days after study entry
From 60 days through 365 days after study entry
The Percentage of Patients Undergoing Splenectomy
Tijdsspanne: Through 365 days after study entry
Through 365 days after study entry
Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey
Tijdsspanne: Weeks 4, 8, and 52 after study entry
Weeks 4, 8, and 52 after study entry
The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score
Tijdsspanne: Through 365 days after study entry
Through 365 days after study entry
The Percentage of Patients Not Completing Study Therapy
Tijdsspanne: 49 days after study entry
49 days after study entry
The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy
Tijdsspanne: Through 1 year after study entry
Through 1 year after study entry

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

HealthCore-NERI

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

  • Hoofdonderzoeker: James Bussel, MD, Weill Medical College, Cornell University
  • Hoofdonderzoeker: Alvin Schmaier, MD, Case Western Reserve University
  • Hoofdonderzoeker: Jodi Segal, MD, Johns Hopkins University
  • Hoofdonderzoeker: Eliot Williams, MD, University of Wisconsin, Madison
  • Hoofdonderzoeker: Thomas Ortel, MD, Duke University
  • Hoofdonderzoeker: James George, MD, The University of Oklahoma
  • Hoofdonderzoeker: Michele Lambert, MD, Children's Hospital of Philadelphia
  • Hoofdonderzoeker: Bruce Sachais, MD, PHD, University of Pennsylvania

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2010

Primaire voltooiing (Werkelijk)

1 maart 2013

Studie voltooiing (Werkelijk)

1 maart 2013

Studieregistratiedata

Eerst ingediend

7 oktober 2009

Eerst ingediend dat voldeed aan de QC-criteria

7 oktober 2009

Eerst geplaatst (Schatting)

8 oktober 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

14 februari 2014

Laatste update ingediend die voldeed aan QC-criteria

2 januari 2014

Laatst geverifieerd

1 januari 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 675
  • U01HL072268 (Subsidie/contract van de Amerikaanse NIH)
  • HL072268
  • HL072033
  • HL072291
  • HL072196
  • HL072289
  • HL072248
  • HL072191
  • HL072299
  • HL072305
  • HL072274
  • HL072028
  • HL072359
  • HL072072
  • HL072355
  • HL072283
  • HL072346
  • HL072331
  • HL072290

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Immuun Trombocytopenische Purpura

Klinische onderzoeken op Dexamethasone USP Micronized

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